MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM; MDS

Model Number MT22495

Device Problem No Audible Alarm (1019)

Patient Problems Hypoglycemia (1912); Seizures (2063)

Event Date 04/10/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Diabetes mellitus is a known cause of hypoglycemia and its associated effects.

Event Description

Patient's mother contacted dexcom on (b)(6) 2016 to report that the patient experienced no audio output from the receiver and a hypoglycemic event on (b)(6) 2016.The patient had a missed low because the receiver did not beep.Patient started to have seizures.Patient's mother called 911 and administered glucagon.The paramedics arrived and the patient had stopped seizing but their blood glucose (bg) was still low.The paramedics tested the patient's bg and he was at 32 mg/dl.The patient refused further iv treatment, so the paramedics had him drink 3 cans of soda and eat 2 peanut butter and jelly sandwiches.The patient recovered and was at 109 mg/dl when the paramedics left.Additionally, the patient's mother tested the audio function of the receiver and it did not beep.No further event or patient information was provided.

Manufacturer Narrative

(b)(4).Describe event or problem - additional, device available for evaluation - additional, initial reporter information - correction, correction/additional information/device evaluation, device evaluated by manufacturer - additional, event problem and evaluation codes - additional.

Event Description

The complaint device was returned for evaluation.The device was visually inspected and no defects were found.A "try it" manual test was performed and speaker sounded.The reported event of no audio output was not confirmed.A root cause could not be determined.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM
• Type of Device: MDS
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence drive; san diego CA 92121
• Manufacturer (Section G): DEXCOM, INC.; 6340 sequence drive; san diego CA 92121
• Manufacturer Contact: kipp durbin ; 6340 sequence drive; san diego, CA 92121 ; 8582000200
• MDR Report Key: 5642774
• MDR Text Key: 44775959
• Report Number: 3004753838-2016-02940
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000156
• UDI-Public: (01)00386270000156(241)MT22495(10)5197909(17)NA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 04/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MT22495
• Device Catalogue Number: STK-DR-001
• Device Lot Number: 5197909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 22 YR
• Patient Weight: 75